Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior tibial nerve stimulation (PTNS).
- Who it may be relevant to
- Registry conditions: Rectal Disorders, Low Anterior Resection Syndrome, Low Anterior Resection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy. Surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called Anterior Resection Syndrome (ARS) with varying degrees of severity. Among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used. The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (LARS) and therefore on the quality of life of patients undergoing this type of intervention. Therefore, treatment with PNTS is currently established for the management of LARS symptoms. Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS. It is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment. The investigators´ hypothesis is: Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer.
Interventions
- Device Posterior tibial nerve stimulation (PTNS)
Posterior tibial nerve neurostimulation in postoperative patients treated for rectal neoplasms for 6 weeks at a rate of 2 sessions per week (12 sessions). The sessions will be carried out by the nursing staff of the anorectal functional testing cabinet. The sessions will begin 3 weeks after hospital discharge for patients without lateral ileostomy and after ileostomy closure for patients with lateral ileostomy.
Primary outcome measures
- Efficacy of PTNS (Posterior Tibial Nerve Stimulation) treatment on the incidence and duration of RAS symptoms in patients undergoing anterior rectal resection with sphincter-sparing surgery. [Time frame: 12 months]
- Impact of PTNS on the quality of life (EORTC-QLQ C30) [Time frame: 12 months]
Secondary outcome measures (2)
- LARS Scale [Time frame: 12 months]
- Impact of PTNS on the quality of life (EORTC-QLQ C29) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Patients undergoing elective surgery (scheduled, non-urgent) who underwent anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the Hospital Álvaro Cunqueiro in Vigo after the start date of the study.
- Anastomotic tightness (absence of dehiscence).
- Patients older than 18 years old.
- Acceptance to participate in the study.
Exclusion criteria
- Inability to understand the study instructions and recommendations.
- Dementia or any type of mental disability.
- Palliative surgery.
- Patients with pacemakers.
- Anti-coagulated patients.
- Patients with trophic lesions on the skin of the ankles.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Álvaro Cunqueiro — Vigo
Identifiers
NCT: NCT05368168 · LARS